Occluder pushing device and transport system

ABSTRACT

The present disclosure relates to an occluder pushing device and an occluder delivery system, wherein the pushing device includes a pushing component and a handle. The pushing component includes a pushing tube and a traction element slidably inserted into the pushing tube. The handle is fixedly connected to a proximal end of the pushing tube and internally provided with a moving component and a locking component. The moving component includes a translation mechanism and a rotation mechanism, where the translation mechanism is used to drive the traction element to move axially inside the pushing tube, and the rotation mechanism is used to drive the traction element to rotate axially inside the pushing tube. The locking component is used to lock relative positions of the traction element and the pushing tube, and the rotation mechanism includes a locking structure for locking or releasing linkage between the rotation mechanism and the traction element. The pushing device of the present invention has provided therein the locking component for locking the traction element and the pushing tube in relative positions, such that when the pushing tube pushes the occluder, the relative positions of the traction element and the pushing tube lock the occluder in a folded state, thereby preventing the occluder from being prematurely released before reaching a pre-determined position.

TECHNICAL FIELD

The present disclosure belongs to the technical field of interventionalmedical devices, and relates to an occluder pushing device and adelivery system including the same.

BACKGROUND ART

The use of interventional methods for the treatment of cardiovasculardiseases by catheter technology is currently the commonly usedtreatment. Specifically, various materials, devices and the like areplaced in the heart, arteries, venous vessels and other parts of a humanbody through interventional catheter techniques for the treatment of thecardiovascular diseases.

For example, interventional medical devices, such as an atrial septaldefect (ASD) occluder, a ventricular septal defect (VSD) occluder, apatent ductus arteriosus (PDA) occluder, a patent foramen ovale (PFO)occluder, etc., are delivered through a catheter interventional method,to reach a defect location of the heart to occlude the defect fortreating a congenital heart disease.

When the above-described interventional medical devices are deliveredinto the heart, the artery, the vein blood vessel, the left atrialappendage and the bronchus of the lungs of a human body through adelivery system, the interventional medical devices are usually pushedto a preset location through a flexible pushing component, then theinterventional medical devices are released after the interventionalmedical devices and the pushing component are disconnected, andradiography or ultrasonography is used to confirm whether releasedposition of the interventional medical devices is proper or not, whetherthe interventional medical instruments are unfolded or not, and whetherthe operation effect is satisfactory or not.

In the prior art, during an interventional medical operation, it ispossible for the pushing device easily release the occluder in advancedue to accidental contact, resulting an inaccurate release positionwhich causes the operation to fail.

SUMMARY OF THE DISCLOSURE

Therefore, it is necessary to provide an occluder pushing device and adelivery system to solve the problem that the existing occluder pushingdevice can cause an inaccurate release position due to accidentalcontact.

In one aspect, the present disclosure provides an occluder pushingdevice, including:

a pushing component including a pushing tube and a traction elementslidably inserted into the pushing tube; and

a handle fixedly connected with a proximal end of the pushing tube andinternally provided with a moving component and a locking component,wherein

the moving component includes a translation mechanism and a rotationmechanism, the translation mechanism is configured to drive the tractionelement to move in an axial direction within the pushing tube, and therotation mechanism is configured to drive the traction element to rotatearound an axis within the pushing tube;

the locking component is configured to lock relative positions of thetraction element and the pushing tube; and

the rotation mechanism includes a locking structure for locking orreleasing linkage between the rotation mechanism and the tractionelement.

In one of the embodiments, the translation mechanism includes:

a first rotating element axially provided with a through hole throughwhich the traction element penetrates;

a second rotating element coaxial with the first rotating element;

a linear guide rail and a balance sliding rail which are respectivelyprovided on the first rotating element and the second rotating elementand parallel to a rotation axis of the first rotating element; and

a horizontal driving component configured to drive a proximal end of thetraction element to generate linear reciprocating motion along thelinear guide rail and the balance sliding rail.

In one of the implementations, the horizontal driving componentincludes:

a traction element mounting seat slidably provided on the linear guiderail and the balance sliding rail, the proximal end of the tractionelement being fixed to the traction element mounting seat; and

a pushing part connected with the traction element mounting seat and atleast partially exposed from the handle so as to push the tractionelement mounting seat to move along the linear guide rail and thebalance sliding rail.

In one of the embodiments, the rotation mechanism is provided at an endof the second rotating element far from the first rotating element, andfurther includes:

a base, which is a hollow barrel and is fixed to a housing of thehandle; and

an adjusting rod slidably inserted into the base and rotatably linkedwith the second rotating element;

where the structure is provided on the base and the adjusting rod, andhas a locking state and an unlocking state to respectively restrain andrelease the rotational degree of freedom of the adjusting rod within thebase; and

the locking structure may be in the locking state or the unlocking stateby axially adjusting the relative positions of the adjusting rod and thebase.

In one of the embodiments, a damping edge is provided on a surface ofthe balance sliding rail along a moving direction of the tractionelement mounting seat, and a sliding element which elastically abutsagainst the damping edge is provided in the traction element mountingseat.

In one of the embodiments, the pushing part is axially limited on thetraction element mounting seat, and the first rotating element and thesecond rotating element transmit the traction element mounting seat torotate around the rotation axis of the first rotating element relativeto the pushing part through the linear guide rail and the balancesliding rail.

In one of the embodiments, the locking structure includes:

stopping pieces circumferentially provided at intervals around an innerside wall of the base;

stopping teeth circumferentially provided at intervals around an outerside wall of the adjusting rod, wherein tooth grooves are formed betweenthe adjacent stopping teeth; and

an annular groove circumferentially formed around the inner side wall ofthe base, wherein when the adjusting rod rotates within the base, thestopping teeth rotate within the annular groove; and

the stopping pieces may be clamped in the tooth grooves or the stoppingteeth may be moved into the annular groove by axially adjusting therelative positions of the adjusting rod and the base.

In one of the embodiments, the traction element mounting seat and thepushing part are axially limited through a limiting edge and a limitinggroove which are mutually aligned circumferentially, and the crosssection of the limiting edge and the limiting groove at the matchingposition are circular to achieve the rotation of the traction elementmounting seat relative to the pushing part.

In one of the embodiments, position clamping structures are provided onthe inner side wall of the base and the outer side wall of the adjustingrod, so that the adjusting rod is axially limited in the base withoutinterference of external force.

In one of the embodiments, the rotation mechanism further includes:

a rotary cover fixed at an end of the adjusting rod far from the secondrotating element;

a spring seat surrounding the base; and

a spring elastically pressed between the spring seat and the rotarycover; and

the position clamping structure includes a clamping ring and a firstclamping groove, wherein the clamping ring extends from the inner sidewall of the base radially and abuts against the outer side wall of theadjusting rod; the first clamping groove is circumferentially formedaround the outer side wall of the adjusting rod; and

when the clamping ring is buckled with the first clamping groove, andthe stopping pieces are clamped in the tooth grooves.

In one of the embodiments, the position clamping structure furtherincludes a second clamping groove, wherein the second clamping groove iscircumferentially formed around the outer side wall of the adjustingrod; and

when the clamping ring is buckled with the second clamping groove, thestopping teeth are positioned in the annular groove.

In one of the embodiments, the locking component includes:

a fixing seat fixed in the handle;

a movable element, a pore is formed between the movable element and thefixing seat for the traction element passes through; and

an adjusting structure configured to adjust the pore between the movableelement and the fixing seat so as to lock or release the tractionelement.

In one of the embodiments, the adjustment structure includes:

a sleeve surrounding the fixing seat and the movable element, whereinthe diameter of the minimum inscribed circle of the projection of thesleeve on the cross section perpendicular to the axial direction is lessthan the diameter of the maximum circumscribed circle of the fixing seatand the movable element; and

a locking wheel axially limited in the handle and in threaded connectionwith the sleeve,

wherein a hub of the locking wheel is at least partially exposed fromthe handle to rotate the locking wheel to transmit the sleeve to moveaxially, so that the sleeve grips or releases the fixing seat and themovable element.

In one of the embodiments, a tapered blind hole is formed in the sleeve;a circular truncated cone is formed by the alignment of the movableelement and the fixing seat, and positioned in the tapered blind hole;and an end of the sleeve far from the opening of the tapered blind holeis in threaded connection with the locking wheel through a screw.

Correspondingly, in another aspect, the present disclosure provides anoccluder delivery system which includes the above-described occluderpushing device, and

a delivery sheath, which is a hollow tube, and the pushing tube of thepushing device is slidably inserted into the delivery sheath; and

a sheath core connected to a proximal end of the delivery sheath andconfigured to adjust a bending direction of the delivery sheath so thatthe pushing tube pushes the occluder to a defect to be occluded alongthe delivery sheath.

In one of the embodiments, the delivery system further includes ahemostatic valve, wherein a hollow guide sheath is detachably connectedbetween the delivery sheath and the hemostatic valve, and an innercavity of the guide sheath is communicated with an inner cavity of thedelivery sheath and an inner cavity of the hemostatic valve.

In one of the embodiments, the delivery system further includes apreloader detachably connected to a distal end of the guide sheath, andthe preloader includes a horn section, an interface section and aconnecting section connected between the horn section and the interfacesection.

The above-described occluder pushing device and the delivery system havethe beneficial effects that the locking component for locking thetraction element and the pushing tube at the relative positions areprovided in the occluder pushing device, so that when the occluder ispushed by the pushing tube, the relative positions of the tractionelement and the pushing tube may maintain the state of the occluder,thereby avoiding an inaccurate releasing position of the occluder due toaccidentally touching the pushing device.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to more clearly illustrate the embodiments of the presentdisclosure or the technical solutions in the prior art, the drawingsused in the description of the embodiments or the prior art will bebriefly described below. Obviously, the drawings depicted hereinafterare only some embodiments of the present disclosure, and a personskilled in the art would obtain drawings of other embodiments from thedrawings herein without involving any inventive effort.

FIG. 1 is a schematic diagram of an occluder delivery system, in which aproximal end of a delivery sheath is connected to a distal end of aguide sheath after an occluder is received into the guide sheath by apreloader;

FIG. 2 is a structural schematic diagram of an occluder;

FIG. 3 is a structural schematic diagram of an occluder pushing device;

FIG. 4 is a schematic diagram of the internal structure of the pushingdevice shown in FIG. 3;

FIG. 5a is an enlarged structural assembly schematic diagram showing theportion in circle A in FIG. 2 and the portion in circle B in FIG. 3;

FIG. 5b is an enlarged structural diagram of the portion in circle C inFIG. 4;

FIG. 6 is a top view of the internal structure of the pushing deviceshown in FIG. 4;

FIG. 7 is a structural diagram of a locking component shown in FIG. 6;

FIG. 8 is a sectional view of the locking component shown in FIG. 7;

FIG. 9 is a structural diagram of a translation mechanism shown in FIG.6;

FIG. 10 is a bottom view of the translation mechanism shown in FIG. 9;

FIG. 11 is a structural diagram of a horizontal driving component of thetranslation mechanism shown in FIG. 9;

FIG. 12 is an exploded structural diagram of the horizontal drivingcomponent of the translation mechanism shown in FIG. 9;

FIG. 13 is a connection schematic diagram of a traction element and atraction element mounting seat;

FIG. 14 is a structural diagram of a second rotating element;

FIG. 15 is an axial sectional view of a rotation mechanism;

FIG. 16 is a structural diagram of a base of the rotation mechanism;

FIG. 17 is a structural diagram of an adjusting rod of the rotationmechanism;

FIG. 18 is an end view, close to the second rotating element, of theadjusting rod shown in FIG. 17;

FIG. 19 is an assembly schematic diagram of the second rotating element,the adjusting rod and the base;

FIG. 20 is a sectional view taken along a section line I-I in FIG. 19;

FIG. 21 is a state diagram showing the adjusting rod being axiallyrotatable relative to the base;

FIG. 22 is a state diagram showing an adjusting rod being axiallylimited to the base;

FIG. 23 is a structural schematic diagram of the preloader;

FIG. 24 is a state diagram of the occluder during the operation of thepushing device;

FIG. 25 is an enlarged structural view of the portion in circle D ofFIG. 24;

FIG. 26 is another state diagram of the occluder during the operation ofthe pushing device (when the occluder is fully folded);

FIG. 27 is a schematic diagram showing a pushing component being pulledto a proximal end to advance the occluder into the guide sheath throughthe preloader; and

FIG. 28 is a schematic diagram of a pushing device pushing out theoccluder through the delivery sheath after the occluder passes through ahemostatic valve and the guide sheath when the guide sheath is connectedwith the delivery sheath.

DETAILED DESCRIPTION OF THE DISCLOSURE

To facilitate an understanding of the present disclosure, the presentdisclosure will be described more fully hereinafter with reference tothe accompanying drawings. Preferred implementations of the presentdisclosure are illustrated in the drawings. The present disclosure may,however, be embodied in many different forms and should not be construedas being limited to the implementations set forth herein. Rather, theseimplementations are provided so that the disclosure will be understoodmore thoroughly and completely.

It should be noted that the terms “distal end” and “proximal end” areused as terms of orientation commonly used in the field ofinterventional medical devices, where the “distal end” refers to the endfar away from an operator during the operation and the “proximal end”refers to the end close to the operator during the operation. The axialdirection refers to a direction parallel to the line connecting thecenter of the distal end and the center of the proximal end of themedical device; and the radial direction refers to a directionperpendicular to the axial direction.

Referring to FIGS. 1-4 and FIG. 5a , an occluder delivery systemincludes a pushing device 20, a delivery sheath 60, and a sheath core70. The pushing device 20 includes a pushing component 22 and a handle21. The pushing component 22 includes a pushing tube 221 and a tractionelement 222 slidably inserted inside the pushing tube 221; and thehandle 21 is internally provided with a moving component and a lockingcomponent 214 which may lock the traction element 222 and the pushingtube 221 in relative positions. The moving component includes atranslation mechanism 215 and a rotation mechanism 216, wherein thetranslation mechanism 215 is configured to drive the traction element222 to move in an axial direction within the pushing tube 221; therotation mechanism 216 is configured to drive the traction element 222to rotate around an axis within the pushing tube 221; and the rotationmechanism 216 includes a locking structure for locking or releasing thelinkage between the rotation mechanism 216 and the traction element 222.Thus, it is possible to prevent the situation where the rotationmechanism 216 drives the pulling element 222 to rotate around the axiswithin the pushing tube 221 due to accidental touching of the rotationmechanism 216 during the operation, thereby improving the operationaccuracy of the pushing device 20.

Specifically, distal ends of the pushing tube 221 and the tractionelement 222 of the pushing component 22 are detachably connected to aproximal end and a distal end of the occluder 10, respectively, and thetranslation mechanism 215 enables the proximal end of the occluder 10 tobe close to, or far away from, the distal end of the occluder 10 bycontrolling a relative position of the traction element 222 in thepushing tube 221 so as to unfold or fold the occluder 10. The lockingcomponent 214 locks the traction element 222 in a relative position withrespect to the pushing tube 221 to prevent accidental touching of thepushing device 20 causing the traction element 222 to move along thepushing tube 221 to release the occluder 10 in advance.

Of course, it should be understood that in some embodiments, thedelivery sheath 60 is a hollow tube and a bending direction of thedelivery sheath 60 is adjusted by the sheath core 70 connected to aproximal end of the delivery sheath 60, so that the pushing tube 221pushes the occluder 10 along the delivery sheath 60 to a defect to beoccluded.

In some embodiments, the delivery system further includes a hemostaticvalve 50, wherein a hollow guide sheath 30 is detachably connectedbetween the delivery sheath 60 and the hemostatic valve 50, and an innercavity of the guide sheath 30 is communicated with an inner cavity ofthe delivery sheath 60 and an inner cavity of the hemostatic valve 50,such that the occluder 10 is pushed by the delivery sheath 60 after thefolded occluder 10 is received into the guide sheath 30 in advance.

Referring also to FIGS. 1 and 24, in some embodiments, a preloader 40 isdetachably connected to a distal end of the guide sheath 30. Referringto FIG. 23, the preloader 40 includes a horn section 41, an interfacesection 43 and a connecting section 42 connected between the hornsection 41 and the interface section 43. The horn section 41 is formedwith a large outwardly-extending opening to receive the occluder 10 intothe guide sheath 30 by pulling the pushing component 22. It will beunderstood that the manner in which the interface section 43 isdetachably connected with the guide sheath 30 is through a threadedconnection or a buckle connection, such that after the occluder 10 isreceived in the guide sheath 30, the preloader 40 is removed and theproximal end of the delivery sheath 60 is connected to the distal end ofthe guide sheath 30.

Referring also to FIGS. 2, 3, and 5 a, in some embodiments, the occluder10 includes a mesh disc 11, a flow blocking film 15, and a suturing part16 for suturing the mesh disc 11 to the flow blocking film 15. To enablethe distal end and the proximal end of the occluder 10 to be detachablyconnected with the distal ends of the pushing tube 221 and the tractionelement 222, respectively, a distal end plug head 12 and a proximal endbolt 13 are arranged at the distal end and the proximal end,respectively, of the occluder 10. The distal end plug head 12 isconnected with an external thread 2221 of the traction element 222through a locking element 14 with an internal thread 141, and theproximal end bolt 13 is provided with an external thread 131 thatcorresponds with the internal thread 2211 provided at the distal end ofthe pushing tube 221. Further, the connection with the occluder 10 maybe removed or established by simply rotating the pushing tube 221 andthe traction element 222 when releasing or recovering the occluder 10.Of course, it should be understood that, referring to FIG. 25, theproximal end bolt 13 is provided with a locking hole 132 through whichthe locking element 14 passes through and locks. The traction element222 moves in the axial direction relative to the pushing tube 221 toenable the locking element 14 to drive the distal end plug head 12 to beclose to or far away from the proximal end bolt 13 to unfold or fold theoccluder 10.

It should be understood that, in other embodiments, the internal thread141 may not be provided at the proximal end of the locking element 14,and the locking element 14 may be detachably connected with the tractionelement 222 by a buckle. In other words, the connection between thelocking element 14 and the traction element 222 may be accomplished inother ways, which will not be specifically enumerated herein, so long asa detachable connection between the locking element 14 and the tractionelement 222 is ensured.

Referring also to FIGS. 4 and 5 b, in order to enable the tractionelement 222 to move within the pushing tube 221, a proximal end of thepushing tube 221 is mounted to a housing of the handle 21 through afixing element 213. In order to facilitate the assembly of internalmembers of the handle 21, the housing of the handle 21 is formed byenclosing a cover 212 and a bottom housing 211. A corresponding fixingelement 213 fixes the proximal end of the pushing tube 221 to the bottomhousing 211 and enables the traction element 222 to pass through thepushing tube 221, a proximal end of the traction element 222 isconnected to the translation mechanism 215, and the traction element 222moves within the pushing tube 221 as driven by the translation mechanism215. It should be understood that the proximal end of the tractionelement 222 passes through the proximal end of the pushing tube 221 toconnect to the translation mechanism 215, and the locking component 214connected to the traction element 222 can lock or release the tractionelement 222, thereby locking the relative positions between the tractionelement 222 and the pushing tube 221.

Referring also to FIGS. 6-8, in some embodiments, the locking component214 includes a fixing seat 2141, a movable element 2142, and anadjusting structure for adjusting a pore 2145 between the movableelement 2142 and the fixing seat 2141. It should be understood that theadjusting structure may lock or release the traction element 222 byadjusting the size of the pore 2145 in such a manner that the movableelement 2142 may clamp the fixing seat 2141 by pressing, or in such amanner that an annular element surrounding the movable element 2142 andthe fixing seat 2141 may grip the movable element 2142 and the fixingseat 2141 when the annular element moves axially. The adjustingstructure will be further described below with regard to how thegripping is accomplished.

Referring also to FIGS. 7 and 8, in some embodiments, the adjustingstructure includes a sleeve 2143 surrounding the fixing seat 2141 andthe movable element 2142, and a locking wheel 2144 that moves the sleeve2143 axially relative to the fixing seat 2141 and the movable element2142.

Specifically, the fixing seat 2141 is fixed in the handle 21 and thesleeve 2143 is connected with the locking wheel 2144 by threads. Thus,the rotation of the locking wheel 2144 may drive the sleeve 2143 to moveaxially to grip or release the fixing seat 2141 and the movable element2142, thereby locking the traction element 222, and further locking orreleasing the traction element 222 passing through the pore 2145 betweenthe movable element 2142 and the fixing seat 2141. It should beunderstood that the diameter of the minimum inscribed circle of theprojection of the sleeve 2143 on the cross section perpendicular to theaxial direction is less than the diameter of the maximum circumscribedcircle of the fixing seat 2141 and the movable element 2142; thisensures that a clamping force on the traction element 222 may be createdby the gripping of the fixing seat 2141 and the movable element 2142when the sleeve 2143 is moved axially relative to the fixing seat 2141and the movable element 2142. Of course, this axial relative movementrequires defining the axial relative positions of the locking wheel 2144and the fixing seat 2141. Referring to FIG. 8, a radially outwardlyformed side edge 21411 of the fixing seat 2141 axially limits the fixingseat 2141 to the bottom housing 212 of the handle 21. Similarly, thelocking wheel 2144 is also axially limited to the bottom housing 212 ofthe handle 21, and to facilitate the operation of the locking wheel2144, a hub 21441 of the locking wheel 2144 is at least partiallyexposed from the handle 21.

Continuing to refer to FIG. 8, in some embodiments, a tapered blind hole21431 is formed in the sleeve 2143; a circular truncated cone is formedby the alignment of the movable element 2142 and the fixing seat 2141,and the circular truncated cone is positioned in the tapered blind hole21431; an end 21431 b that is far away from the opening 21431 a of thetapered blind hole 21431 of the sleeve 2143 is threadably connected withthe locking wheel 2144 through a screw 21432. The clamping or looseningbetween the fixing seat 2141 and the movable element 2142 is achievedwhen the tapered blind hole 21431 is close to or far away from thecircular truncated cone, respectively. Of course, in the presentembodiment, the threaded transmission by means of the screw 21432 isonly to reduce the space occupied by the structure, and to facilitatethe arrangement of the locking wheel 2144 having a larger diameter toimprove the torsion-resistant performance. It should be understood thatthe sleeve 2143 may also be axially driven by directly matching theinternal thread of the locking wheel 2144 with the external thread ofthe outer wall of the sleeve 2143.

Referring also to FIGS. 6 and 9, in some embodiments, the translationmechanism 215 includes a first rotating element 2151, a second rotatingelement 2152, a linear guide rail 2153, a balance sliding rail 2155, anda horizontal driving component 2154. The first rotating element 2151 isaxially provided with a through hole 21541 b through which the tractionelement 222 extends. The second rotating element 2152 is coaxial withthe first rotating element 2151; and the linear guide rail 2153 and thebalance sliding rail 2155 are provided on the first rotating element2151 and the second rotating element 2152, respectively, in a manner ofbeing parallel to a rotation axis of the first rotating element 2151.The proximal end of the traction element 222 passes through the throughhole 21541 b of the first rotating element 2151 and is fixed to thehorizontal driving component 2154 so as to allow linear reciprocatingmotion along the linear guide rail 2153 and the balance sliding rail2155 under the driving force of the horizontal driving component 2154,and then axially moves relative to the pushing tube 221 fixed to thehandle 21 so as to fold or unfold the occluder 10.

Referring also to FIGS. 9 and 13, in some embodiments, the horizontaldriving component 2154 includes a traction element mounting seat 21541and a pushing part 21542 connected with the traction element mountingseat 21541. The traction element mounting seat 21541 is slidablyprovided on the linear guide rail 2153 and the balance sliding rail2155, and the proximal end of the traction element 222 is fixed to thetraction element mounting seat 21541. The pushing part 21542 is at leastpartially exposed from the handle 21 so as to push the traction elementmounting seat 21541 to move along the linear guide rail 2153 and thebalance sliding rail 2155. It should be understood that the tractionelement 222 may be fixed by a locking wire 21541 d extending radiallyalong the traction element mounting seat 21541, or may be fixed to thetraction element mounting seat 21541 by other ways such as welding.

Referring to FIG. 12, in some embodiments, in order to prevent thetraction element mounting seat 21541 from pushing too fast without beingblocked while pushing the traction element 222, damping edges 21551 areprovided on the surface of the balance sliding rail 2155 along a movingdirection of the traction element mounting seat 21541, and a slidingelement 21545 which elastically abuts against the damping edges 21551 isprovided in the traction element mounting seat 21541. Thus, when slidingaxially, the traction element mounting seat 21541 will be blocked by thedamping edges 21551 on the surface of the balance sliding rail 2155, sothat the occluder 10 may be slowly released during the operation,thereby reducing the adverse impacts caused by pushing too fast.

Specifically, in order to maintain the sliding element 21545 in a stateof elastically abutting against the damping edges 21551, an elasticelement 21544 may be provided at an end of the sliding element 21545 farfrom the damping edges 21551, so as to urge the sliding element 21545toward the damping edges 21551. It should be understood that a curvedsurface of the sliding element 21545 is usually used to abut against thedamping edges 21551 so as to reduce wear during sliding, or to avoidinconvenience in pushing the traction element mounting seat 21541 causedby excessive blocking.

Referring also to FIGS. 10 and 11, in the above-described embodiments,the traction element mounting seat 21541 is radially formed with thethrough hole 21541 b communicating with one sides of the damping edges21551 to provide a mounting space for the elastic element 21544 and thesliding element 21545. The elastic element 21544 is a spring, and thesliding element 21545 is a ball. The bottom of the spring is pressedagainst the ball to enable the ball to abut against the damping edges21551, and the top of the spring is radially limited along the tractionelement mounting seat 21541 through a fastening element 21543. It shouldbe understood that the fastening element 21543 is a grub screw mountedon one side of the through hole 21541 b, and correspondingly, a threadedhole 21541 a is formed in the traction element mounting seat 21541 tocooperate with the grub screw to fasten and press the spring downwardly.

In some embodiments, the pushing part 21542 is axially limited on thetraction element mounting seat 21541, and the first rotating element2151 and the second rotating element 2152 drive the traction elementmounting seat 21541 to rotate around the rotation axis of the firstrotating element 2151 relative to the pushing part 21542 through thelinear guide rail 2153 and the balance sliding rail 2155. The tractionelement mounting seat 21541 drives the traction element 222 to rotateaxially within the pushing tube 221, thereby connecting or separatingthe traction element with or from the locking element 14 of the occluder10.

In some embodiments, the traction element mounting seat 21541 and thepushing part 21542 are axially limited by a limiting edge 21541 c and alimiting groove 21542 c, which are mutually aligned circumferentially,and the cross section of the limiting edge 21541 c and the limitinggroove 21542 c at the aligned position is circular to allow for therotation of the traction element mounting seat 21541 relative to thepushing part 21542. It should be understood that the limiting edge 21541c may be provided on the traction element mounting seat 21541 or on thepushing part 21542. When the limiting edge 21541 c is provided on thetraction element mounting seat 21541, the pushing part 21542 is providedwith the limiting groove 21542 c aligned with the limiting edge 21541 c;and when the limiting edge 21541 c is provided on the pushing part21542, the traction element 222 is provided with the limiting groove21542 c aligned with the limiting edge 21541 c. In the presentembodiment, as shown in FIG. 12, the traction element mounting seat21541 and the pushing part 21542 are each provided with the limitingedge 21541 c and the limiting groove 21542 c which are aligned with eachother, and it should be understood that the pushing part 21542 includesa pushing part seat 21542 a and a pushing part upper cover 21542 b tofacilitate the assembly of the pushing part 21542 on the tractionelement mounting seat 21541.

In some embodiments, to facilitate the rotation of the traction elementmounting seat 21541 relative to the pushing part 21542, a rotationmechanism 216 is provided at an end of the second rotating element 2152far from the first rotating element 2151. The rotation mechanism 216 isrotated to drive the second rotating element 2152 to rotate, therebydriving the traction element mounting seat 21541 to rotate axiallythrough the linear guide rail 2153 and the balance sliding rail 2155.

Specifically, referring to FIG. 15, in some embodiments, the rotationmechanism 216 includes a base 2161 and an adjusting rod 2162. The base2161 is a hollow barrel and is fixed to the housing of the handle 21;the adjusting rod 2162 is slidably inserted into the base 2161 androtatably linked with the second rotating element 2152. Thus, theadjusting rod 2162 may rotate within the base 2161 to rotate in linkagewith the second rotating element 2152. Referring also to FIGS. 14 and18-20, it should be understood that the second rotating element 2152 isinserted through a rotating shaft control rod 2156 into a slot 21625formed axially along the adjusting rod 2162, and the cross sectionperpendicular to the axis is non-circular, i.e., the slot 21625 allowsthe rotating shaft control rod 2156 to move axially while limiting onlythe rotational degree of freedom of the rotating shaft control rod 2156to achieve rotational linkage around the axis.

In some embodiments, the locking structure is provided on the base 2161and the adjusting rod 2162. The locking structure has a locking stateand an unlocking state in which the rotational degree of freedom of theadjusting rod 2162 within the base 2161 is respectively restrained orreleased; and the locking structure may be in the locking state or theunlocking state by axially adjusting the relative positions of theadjusting rod 2162 and the base 2161. Thus, rotation of the secondrotating member 2152 due to accidentally touching of the adjusting rod2162 during the pushing of the occluder 10 is prevented. The distal endof the traction element 222 fixedly connected to the traction elementmounting seat 21541 is detached from the fastening element of theoccluder 10 by rotating the second rotating member 2152, and if thesecond rotating member 2152 is accidentally rotated, it would cause theoccluder 10 to be accidentally released. Therefore, if the rotation ofthe second rotating member 2152 is prevented, accidental release of theoccluder 10 can be prevented.

Referring also to FIGS. 16-18, in some embodiments, the lockingstructure includes stopping pieces 21612, stopping teeth 21621 and anannular groove 21611. The stopping pieces 21612 are providedcircumferentially at intervals around an inner side wall of the base2161; the stopping teeth 21621 are provided circumferentially atintervals around an outer side wall of the adjusting rod 2162, and toothgrooves 21622 are formed between adjacent stopping teeth 21621. Theannular groove 21611 is provided circumferentially around the inner sidewall of the base 2161. When the adjusting rod 2162 is rotated within thebase 2161, the stopping teeth 21621 may rotate within the annular groove21611. The stopping pieces 21612 may be clamped in the tooth grooves21622 or the stopping teeth 21621 may be moved into the annular groove21611 by axially adjusting the relative positions of the adjusting rod2162 and the base 2161 to limit or release the rotational degree offreedom between the adjusting rod 2162 and the base 2161. It should beunderstood that when the rotational degree of freedom between theadjusting rod 2162 and the base 2161 is limited, even if the adjustingrod 2162 is touched accidently, the adjusting rod 2162 will not rotateaxially, thereby avoiding accidental touching of the pushing device 20causing the traction element 222 to rotate to be disconnected from theoccluder 10, and ensuring the accuracy of the release of the occluder10.

In some embodiments, position clamping structures are provided on theinner side wall of the base 2161 and the outer side wall of theadjusting rod 2162, so that the adjusting rod 2162 may be axiallylimited in the base 2161 without interference by external forces.Further, the adjusting rod 2162 and the base 2161 are kept in a lockedor released state of the rotational degree of freedom, so thataccidental touching resulting in the adjusting rod 2162 being unlockedfrom the rotational degree of freedom of the base 2161 is avoided.

Referring also to FIGS. 15, 17, and 19, in some embodiments, therotation mechanism 216 further includes a rotary cover 2164, a springseat 2165, and a spring 2166 elastically pressed between the spring seat2165 and the rotary cover 2164. The rotary cover 2164 is fixed at an endof the adjusting rod 2162 far away from the second rotating element2152; and the spring seat 2165 surrounds the base 2161. The rotary cover2164 may be fixedly connected with the adjusting rod 2162 through atightening screw 2163, and of course the fixing may also be accomplishedthrough a buckle or the like. In this embodiment, as combined with FIG.21, the position clamping structure includes a clamping ring 21613 and afirst clamping groove 21623. The clamping ring 21613 extends radiallyfrom the inner side wall of the base 2161 and abuts against the outerside wall of the adjusting rod 2162; the first clamping groove 21623 iscircumferentially formed around the outer side wall of the adjusting rod2162; and when the clamping ring 21613 is received inside the firstclamping groove 21623, the stopping pieces 21612 are clamped in thetooth grooves 21622. Thus the adjusting rod 2162 is axially maintainedwith the base 2161 in a state where the rotational degree of freedom islocked under the limitation of the clamping ring 21613 and the firstclamping groove 21623, i.e., the adjusting rod 2162 cannot rotaterelative to the base 2161, so as to prevent the traction element 222from rotating due to accidental touching. When the clamping ring 21613and the first clamping groove 21623 are disengaged, the stopping groovein the adjusting rod 2162 is driven away from the stopping pieces 21612and located in the annular groove 21611 under the elastic force of thespring 2166, so that by rotating the rotary cover 2164 to rotate thetraction element 222, the occluder 10 may be released through thedisengagement from the connection, or may be recovered through theestablishment of the connection.

Preferably, as combined with FIG. 22, the position clamping structurefurther includes a second clamping groove 21624, wherein the secondclamping groove 21624 is circumferentially formed around the outer sidewall of the adjusting rod 2162; and when the clamping ring 21613 isreceived inside the second clamping groove 21624, the stopping teeth21621 are positioned in the annular groove 21611. The alignment of thesecond clamping groove 21624 and the clamping ring 21613 maintains theadjusting rod 2162 and the base 2161 in the released state of therotational degree of freedom, thereby avoiding the situation that therotational degree of freedom of the adjusting rod 2162 is notsufficiently maintained in the released state when the spring 2166fails, thereby improving the safety of operation, and ensuring that notraction element 222 will rotate and be disengaged from the occluder 10due to accidental touching of the pushing device 20.

Referring also to FIGS. 24 and 25, when the pushing device 20 is used todeploy the occlude 10, the pushing component 22 connected with thehandle 21 sequentially passes through the hemostatic valve 50, the guidesheath 30 and the preloader 40, and the pushing tube 221 and thetraction element 222 of the pushing component 22 are connected with theproximal end bolt 13 and the locking element 14 of the occluder 10,respectively. Thus, the traction element 222 may be controlled to movetoward the distal end along the pushing tube 221 by pushing the pushingpart 21542 on the handle 21 to move toward the distal end, leading thefastening element to drive the distal end plugging head 12 away from theproximal end bolt 13 to stretch and shape the occluder 10 axially. Withcontinued pushing on the pushing part 21542 toward the distal end, theoccluder 10 is fully folded as shown in FIG. 26, and the hub 21441 ofthe locking wheel 2144 on the handle 21 is rotated to lock the relativepositions between the traction element 222 and the pushing tube 221, soas to maintain the occluder 10 in the folded state. Referring to FIG.27, pulling the pushing component 22 toward the proximal end may movethe occluder 10 into the guide sheath 30 through the preloader 40. Thepreloader 40 is removed from the guide sheath 30 and the distal end ofthe guide sheath 30 is connected with the proximal end of the deliverysheath 60, so that the operation of loading the occluder 10 into theoccluder delivery system is completed. Referring to FIG. 28, theoccluder 10 is pushed by the occluder delivery system through thedelivery sheath 60 to a pre-determined position where the occluder 10will be unfolded and released. It should be understood that since themovement of the traction element 222 in the push tube 221 is reversiblycontrolled by the pushing device 20, i.e., after unlocking the tractionelement 222 from the locking component 214, the pushing part 21542 ispushed toward the proximal end to allow the traction element 222 todrive the locking wire to be close to the proximal end bolt 13 connectedwith the distal end of the pushing tube 221, and then the occluder 10may be adjusted from the folded state to the unfolded state. In theprocess of adjusting the state of the occluder 10 by the pushing device20, when the traction element mounting seat 21541 slides axially, thetraction element mounting seat 21541 will be blocked by the dampingedges 21551 on the surface of the balance sliding rail 2155, so that theoccluder 10 may be slowly released during the operation, therebyreducing the adverse impacts caused by pushing too quickly.

The various technical features of the above-mentioned embodiments may becombined in any combination, and in order to simplify the description,not all possible combinations of the various technical features of theabove-described embodiments are described, however, as long as there isno conflict between these technical features, they should be allconsidered to be the scope of disclosure contained in this description.

The above embodiments are merely illustrative of several implementationsof the present disclosure, which are described in more detail and arenot to be construed as limiting the scope of the disclosure. It shouldbe noted that several variations and modifications may be made by thoseskilled in the art without departing from the spirit of the disclosure,which all fall within the scope of the disclosure. Therefore, theprotection scope of the disclosure shall be determined by the appendedclaims.

The invention claimed is:
 1. An occluder pushing device, comprising: apushing component comprising a pushing tube and a traction elementslidably inserted into the pushing tube; and a handle fixedly connectedwith a proximal end of the pushing tube and internally provided with alocking component, a translation mechanism and a rotation mechanism;wherein the translation mechanism is configured to drive the tractionelement to move in an axial direction within the pushing tube; therotation mechanism is configured to drive the traction element to rotatearound an axis within the pushing tube; the locking component isconfigured to lock relative positions of the traction element and thepushing tube; and the rotation mechanism comprises a locking structurefor locking or releasing linkage between the rotation mechanism and thetraction element.
 2. The occluder pushing device of claim 1, wherein thetranslation mechanism comprises: a first rotating element axiallyprovided with a through hole through which the traction element extends;a second rotating element coaxial with the first rotating element; alinear guide rail and a balance sliding rail respectively provided onthe first rotating element and the second rotating element and beingparallel to a rotation axis of the first rotating element; and ahorizontal driving component configured to drive a proximal end of thetraction element to generate linear reciprocating motion along thelinear guide rail and the balance sliding rail.
 3. The occluder pushingdevice of claim 2, wherein the horizontal driving component comprises: atraction element mounting seat slidably provided on the linear guiderail and the balance sliding rail, wherein the proximal end of thetraction element is fixed to the traction element mounting seat; and apushing part connected with the traction element mounting seat and atleast partially exposed from the handle so as to push the tractionelement mounting seat to move along the linear guide rail and thebalance sliding rail.
 4. The occluder pushing device of claim 3, whereina damping edge is provided on a surface of the balance sliding railalong a moving direction of the traction element mounting seat, and asliding element which elastically abuts against the damping edge isprovided in the traction element mounting seat.
 5. The occluder pushingdevice of claim 3, wherein the pushing part is axially limited on thetraction element mounting seat, and the first rotating element and thesecond rotating element transmit the traction element mounting seat torotate around the rotation axis of the first rotating element relativeto the pushing part through the linear guide rail and the balancesliding rail.
 6. The occluder pushing device of claim 5, wherein thetraction element mounting seat and the pushing part are axially limitedthrough a limiting edge and a limiting groove which are mutually alignedcircumferentially, and the cross section of the limiting edge and thelimiting groove at the matching position are circular to achieve therotation of the traction element mounting seat relative to the pushingpart.
 7. The occluder pushing device of claim 2, wherein the rotationmechanism is provided at an end of the second rotating element far fromthe first rotating element, and the rotation mechanism furthercomprises: a base, which is a hollow barrel and is fixed to a housing ofthe handle; and an adjusting rod slidably inserted into the base androtatably linked with the second rotating element, wherein the lockingstructure is provided on the base and the adjusting rod, and has alocked state and an unlocked state to respectively restrain and releasethe rotational degree of freedom of the adjusting rod within the base;and wherein the locking structure is capable of being placed in thelocked state or the unlocked state by axially adjusting relativepositions of the adjusting rod and the base.
 8. The occluder pushingdevice of claim 7, wherein the locking structure comprises: stoppingpieces circumferentially provided at intervals around an inner side wallof the base; stopping teeth circumferentially provided at intervalsaround an outer side wall of the adjusting rod, wherein tooth groovesare formed between the adjacent stopping teeth; and an annular groovecircumferentially formed around the inner side wall of the base, whereinwhen the adjusting rod rotates within the base, the stopping teethrotate in the annular groove; and wherein the stopping pieces arecapable of being clamped in the tooth grooves or the stopping teeth arecapable of being moved into the annular groove by axially adjusting therelative positions of the adjusting rod and the base.
 9. The occluderpushing device of claim 8, wherein position clamping structures areprovided on the inner side wall of the base and the outer side wall ofthe adjusting rod, so that the adjusting rod is axially limited in thebase without interference of external force.
 10. The occluder pushingdevice of claim 9, wherein the rotation mechanism further comprises: arotary cover fixed at an end of the adjusting rod far from the secondrotating element; a spring seat surrounding the base; and a springelastically pressed between the spring seat and the rotary cover; andwherein the position clamping structure comprises a clamping ring and afirst clamping groove, wherein the clamping ring extends radially fromthe inner side wall of the base and abuts against the outer side wall ofthe adjusting rod; the first clamping groove is circumferentially formedaround the outer side wall of the adjusting rod; and when the clampingring is buckled with the first clamping groove, the stopping pieces areclamped in the tooth grooves.
 11. The occluder pushing device of claim10, wherein the position clamping structure further comprises a secondclamping groove, wherein the second clamping groove is circumferentiallyformed around the outer side wall of the adjusting rod; and when theclamping ring is buckled with the second clamping groove, the stoppingteeth are positioned in the annular groove.
 12. The occluder pushingdevice of claim 1, wherein the locking component comprises: a fixingseat fixed in the handle; a movable element, a pore is formed betweenthe movable element and the fixing seat for the traction element to passthrough; and an adjusting structure configured to adjust the porebetween the movable element and the fixing seat so as to lock or releasethe traction element.
 13. The occluder pushing device of claim 12,wherein the adjusting structure comprises: a sleeve surrounding thefixing seat and the movable element, wherein the diameter of the minimuminscribed circle of the projection of the sleeve on the cross sectionperpendicular to the axial direction is less than the diameter of themaximum circumscribed circle of the fixing seat and the movable element;and a locking wheel axially limited in the handle and in threadedconnection with the sleeve, wherein a hub of the locking wheel is atleast partially exposed from the handle to rotate the locking wheel totransmit the sleeve to move axially, so that the sleeve grips orreleases the fixing seat and the movable element.
 14. The occluderpushing device of claim 13, wherein a tapered blind hole is formed inthe sleeve; a circular truncated cone is formed by the alignment of themovable element and the fixing seat, and positioned in the tapered blindhole; and an end of the sleeve far from the opening of the tapered blindhole is in threaded connection with the locking wheel through a screw.15. An occluder delivery system, comprising the occluder pushing deviceof claim 1, and a delivery sheath, which is a hollow tube, and thepushing tube of the occluder pushing device is slidably inserted intothe delivery sheath; and a sheath core connected to a proximal end ofthe delivery sheath and configured to adjust a bending direction of thedelivery sheath so that the pushing tube pushes the occluder to a defectto be occluded along the delivery sheath.
 16. The occluder deliverysystem of claim 15, wherein the delivery system further comprises ahemostatic valve, wherein a hollow guide sheath is detachably connectedbetween the delivery sheath and the hemostatic valve, and an innercavity of the guide sheath is communicated with an inner cavity of thedelivery sheath and an inner cavity of the hemostatic valve.
 17. Theoccluder delivery system of claim 16, wherein the delivery systemfurther comprises a preloader detachably connected to a distal end ofthe guide sheath, and the preloader comprises a horn section and aninterface section, and a connecting section connected between the hornsection and the interface section.